MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0301

Device Problems Break (1069); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.The investigation determined the reported cable break resulting in the inability to straighten the tip appears to be related to user technique.The reported noise and mechanical issue with the knob (unable to straighten guide) were likely secondary effects to the cable break.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.

Event Description

This report is filed for the cable break.It was reported that during device preparation the knob on the steerable guide catheter (sgc) was being turned towards the negative (minus) direction when an audible click noise was heard and the sgc tip no longer responded to the knob.The device was not used.Another sgc was prepared and used in the mitraclip procedure.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6578822
• MDR Text Key: 75722468
• Report Number: 2024168-2017-04338
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: (01)08717648216824(17)171206(10)61206U144
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2017
• Device Catalogue Number: SGC0301
• Device Lot Number: 61206U144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1